Seveso II Directive - Regulatory Affairs and Case Studies - Past Exam, Exams for Integrated Case Studies. Agra University
senagala_8768 April 2013

Seveso II Directive - Regulatory Affairs and Case Studies - Past Exam, Exams for Integrated Case Studies. Agra University

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Main points of this past exam are: Seveso Ii Directive, European Medical Device Directive, European Market, Drugs Administration, Medical Devices, Medical Device Organisation, Quality Systems Requirements, Product Liabil...
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Ollscoil na hÉireann, Gaillimh

Page 1

Semester I Examinations 2010/2011

Exam Code(s)

4HF2, 1APE1, 1APE2

Exam(s) B. Sc (Health and Safety Systems) Master of Applied Science (Enterprise Systems)

Module Code(s) IE447 Module(s) Regulatory Affairs and Case Studies

Paper No. 1 Repeat Paper External Examiner(s)

Dr. F. Dick

Internal Examiner(s)

*Dr P. Donnellan Prof. P. McHugh


Answer any FOUR questions.


3 Hours

No. of Pages Cover + 1 page

College/Discipline Engineering & Informatics/Industrial Engineering Course Co- ordinator(s)

Ms. M. Kelly


Page 2

Q1 a) The European Medical Device Directive (MDD) addresses safety issues for medical

devices sold in the European market. Explain how it achieves this task?

(12 marks)

b) Explain the role of the US Food and Drugs Administration (FDA) in protecting public safety

for medical devices, and also explain how it carries out this important role form a regulatory

point of view for companies manufacturing medical devices in Europe for use in the US

market place.

(13 marks)

Q 2 a) The design process in a medical device organisation is a critical step in assuring customer

safety through device quality. Explain how you would measure the quality of the design

process using ISO13485 Quality Systems Requirements for Medical Devices. (i.e. section

7.3 of the standard) (15 marks)

b) List five other key Procedures required by the ISO13485 Standard and explain their

importance from a regulatory point of view.

(10 marks)

Q3 There is a high degree of similarity between environmental and safety management systems

e.g. ISO14001 and OHSAS18001. Explain the main requirements of these systems focusing

on the common requirements. In your answer show how you would approach the

development of an integrated system for EH&S management. (25 marks)

Q4 Write short explanatory notes on Three of the following topics: (8 1 /3 Marks each)

i) A Product Liability Prevention Programme ii) The importance of the Seveso II Directive iii) Risk Management e.g. as presented in the DVD Risk Maker Risk Taker or other

examples of your choice.

iv) The HACCP Process for food safety v) The most relevant sections of the Product Safety Regulations, 2004, for a producer

of consumer products in the EU?

Q5 The Machinery Regulations (S.I, 407 of 2008) came into effect on December 2009. Explain

the significance of this directive to:

a) A current manufacturer of machinery b) A company that does not manufacture machinery but who operates several machines

both old (Pre 1990) and new (Post 2009) in their Company.

In your answer you should define a machine, a manufacturer and the CE approval process.

(25 marks)

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